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Study aim
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Determining the effect of BTMC-1 medicinal product on the serum levels of RF and antiCCP, the serum levels of pro-inflammatory cytokines (IL6, TNFα and IL1), the number of white blood cells, CRP and ESR levels, pain, disease severity, morning joint stiffness duration, the number of tender and swollen joints, the disability of RA patients
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Design
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A randomized,double-blinded,controlled phase 2 clinical trialwith factorial groups on 40 patients. Randomization will be done based on the permutation of random blocks.
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Settings and conduct
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Sample collection will be done in Imam Khomeini Hospital and they will be introduced to the laboratory. Sampling and completing the questionnaires will be done two times (before and after the intervention). The intervention and placebo will have the same appearance, and the doctor and patients will be blinded.
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Participants/Inclusion and exclusion criteria
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Informed consent of the patient, confirmation of rheumatoid arthritis criteria , between 20 to 65 years old, female, with active rheumatoid arthritis (DAS28 between 2.6 and 5.1) , constant treatment before and during the intervention, the duration of the disease should be less than 5 years, using methotrexate as the main treatment;Lack of consent to continue participating ,Suffering from another disease, consumption of any vitamins, minerals and nutritional supplements, patients with DAS28˃5.1, pregnancy and lactation, being relatives of patients, irregular consumption of the intervention, excessive consumption of fruit and natural fruit juices during the intervention
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Intervention groups
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Intervention: BTMC-1 (800 mg of matricaria chamomile hydroalcoholic extract per capsule), two capsules will be consumed daily for 45 days .control group will receive caspules which just have basic ingrediants.
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Main outcome variables
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Pro-inflammatory cytokines, RF and anticcp ,pain, disease severity and disability